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Evaluation of Local Anesthetic at Incision Site

The Evaluation of Pre-incisional and Post-closure Local Anesthetic vs. Normal Saline on Postoperative Pain in Pediatric Appendectomies

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02483689
Enrollment
100
Registered
2015-06-29
Start date
2015-08-31
Completion date
2020-07-31
Last updated
2018-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis, Post Operative Pain

Keywords

Post Operative Pain, Appendicitis, Appendectomy, Local Anesthetic, Saline, Pain Management, Surgery, Recovery

Brief summary

Patient will have usual appendectomy surgery with an injection of local or saline at incision site either before or after the incision at random. The clinical hypothesis of this trial is that pediatric patients who undergo a local anesthetic pre-incisional and/or post-incisional will reduce the amount of postoperative pain and therefore reduce the amount of analgesics required to keep the patient satisfied. Primary: To determine if local anesthetic reduces postoperative pain. Secondary: To assess the timing of local anesthetic injection affects postoperative pain.

Detailed description

This is a prospective randomized-controlled pilot study of 100 pediatric subjects, recruited through Phoenix Children's Hospital and Pediatric Surgeons of Phoenix, who will undergo a laparoscopic appendectomy (LA) for acute non-perforated appendicitis. The reviewer and subject will be blind to the treatment to help prevent bias. The subjects will be randomized by envelope using a random number generator, and the infiltrated solution will be given to the surgeon by the pharmacy. The subjects will be approached preoperatively and will be divided into three groups: pre-incisional injection of local anesthetic, post-incisional injection of local anesthetic, and (pre or post) injection of saline as the control. All patients will have a standard 3 port laparoscopic appendectomy, port placement, port and instrument type, and operative technique will be determined by the surgeon's usual practice. On induction, the following protocol will be utilized: a 2 mg/kg bolus of propofol, 1.5 mg/kg of lidocaine, 0.1 mg/kg of morphine, and 0.6 mg/kg of rocuronium. A standardized anesthetic, using a mixture of sevoflurane in oxygen and air, will be utilized. Once the appendectomy is complete, a single dose of 0.5 mg/kg of ketorolac will be given prior to extubation. A total of 0.5 mL/kg of 0.25% Bupivicaine or saline, up to a maximum of 30 cc, will be injected using a 22g needle. Pre-incision: local will be to be given intradermally and onto the peritoneum under direct vision; post-closure local will be injected intradermally after closure. The subjects will be assessed for postoperative pain immediately upon wakening, and then 1, 2, 4, 8, 12, and 24 hours after the LA procedure by the bedside nurse by using the VAS and by measuring the total amount of opioid use.

Interventions

DRUGPre Incisional Local Anesthetic

Patient will be given a total of 0.5 mL/kg of 0.25% Bupivicaine either pre-incision: local will be to be given intradermally and onto the peritoneum under direct vision; or post-closure local will be injected intradermally after closure

OTHERPre-Incisional Saline

Patient will be given a max of 30 cc injected through a 22g needle to area of incision.

DRUGPost-Closure Local Anesthetic

Patient will be given a total of 0.5 mL/kg of 0.25% Bupivicaine either pre-incision: local will be to be given intradermally and onto the peritoneum under direct vision; or post-closure local will be injected intradermally after closure

OTHERPost-Closure Saline

Patient will be given a max of 30 cc injected through a 22g needle after closing sutures were made.

Sponsors

Valley Anesthesiology Consultants
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
9 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients undergoing Appendectomy for acute non-perforated appendicitis Must be between 9-17 years old

Exclusion criteria

* n/a

Design outcomes

Primary

MeasureTime frameDescription
Amount of Post Operative Pain Patients Experience12 hoursThe subjects will be assessed for post-operative pain immediately upon wakening, then at 1, 2, 4, 8, and 12 hours after procedure.

Secondary

MeasureTime frameDescription
The total amount of opioid use24 HoursThis will be completed by looking at the total amount of morphine equivalants given to the patient during the first 24 hours of their hospital stay.

Countries

United States

Contacts

Primary ContactRaj Singhal, MD
rsinghal@valley.md
Backup ContactVanessa Pohl, BS
vpohl@phoenixchildrens.com6029334482

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026